www.fdanews.com/articles/205451-roche-gets-ce-mark-for-its-new-cobas-5800-system
Roche Gets CE Mark for Its New cobas 5800 System
November 22, 2021
Roche has received a CE mark for its new cobas 5800 System, a compact real-time polymerase chain reaction (PCR) instrument designed for use in laboratories of all sizes.
The system offers a fully automated workflow that includes sample supply, transfer and preparation, amplification and detection, result calculation and delivery to the laboratory’s information system.
Roche said it anticipates gaining FDA’s approval for the new system in the third quarter of 2022.